Hancock Jaffe Laboratories (NSDQ:HJLI) said yesterday that six-month data from its in-human VenoValve study showed that the first five patients observed displayed improvements in all study endpoints.
Principal investigator Dr. Jorge Hernando Ulloa reported that the patients showed 10% improvement in reflux, 2% improvement in disease manifestations (VCSS scores) and 13% improvements in pain (VAS scores) compared to levels at 90 days following VenoValve surgery.
Reflux is the primary end point for the ongoing VenoValve trial in Bogota, Colombia, and is the main cause of severe chronic venous insufficiency (CVI) of the deep vein system. HJLI launched the trial in February.
Along with the first five patients, three more patients have been enrolled in the trial, one of which is at 90 days post-operation while the remaining two are at 60 days after surgery. HJLI said a ninth patient has been enrolled and was successfully implanted this month.
The company added that its next steps include enrolling and implanting a VenoValve in a 10th patient and reengaging with the FDA as it prepares to file an investigational device exemption application for a U.S. pivotal trial.
The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said.
“If our patients had merely maintained their 90-day improvement levels, that would have been a positive result,” HJLI CEO Robert Berman said in a news release. “Instead, our patients have continued to show improvement. What is equally as impressive is the extensive healing of the venous ulcer at only 60 days post-VenoValve surgery. Our goal with the VenoValve is to improve the lives of patients with CVI and this data and the pictures show that we are on the right path.”
“It is gratifying to be able to help patients that are in such distress and have no other effective treatment options,” added SVP & chief medical officer Dr. Marc Glickman. “The venous ulcers that we typically encounter are extremely painful and negatively impact all aspects of the patients’ lives. The results that we are seeing so far in terms of ulcer healing are beyond my expectations.”
Shares of HJLI were down -0.8% at 78¢ per share in midday trading today.